CHIMAERA Hip Fracture System 1 (REF 99-T93130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242514299), received between May 11, 2022 and May 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2022Inadequacy of Device Shape and/or Size; Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: PRODUCT CODE: 99-T93130. BATCH NUMBER: B1693150. DATE OF INITIAL SURGERY: (B)(6) 2022. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: 68 YEARS, MALE, REVISION KNEE REPLACEMENT. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. EVENT DESCRIPTION: PRODUCT WAS MODIFIED BY SURGEON AND TECHNICAL WORKSHOP INTRA OPERATIVELY TO MAKE IT FIT IN THE PATIENT'S FEMUR. THE INCIDENT OCCURRED RIGHT AT THE BEGINNING OF THE PROCEDURE WHEN THE GUIDE WIRE WAS INSERTED AND IT GOT STUCK. UPON FURTHER IMAGING INVESTIGATION IT WAS DISCOVERED THAT THE PATIENT HAS A REVISION KNEE IMPLANT WITH A STEM RUNNING FROM THE DISTAL END TO THE PROXIMAL HALF OF THE FEMUR AS WELL A CEMENT MANTLE. THE WIRE COULDN'T BE ADVANCED ANY FURTHER AND THIS MEANT THAT THE NAIL COULD NOT BE INSERTED AS PER INTENDED APPROACH. THE MAJOR ISSUE WAS THAT OUR IMPLANT WOULD BE TOO LONG AND THAT IT COULD NOT INSERTED TO THE DESIRED DEPTH AS PER SUBSCRIBED USE. ON 27 APRIL 2022, THE DOCTOR INFORMED ME THAT THERE WAS LOSS OF CORRECTION IN THE PATIENT. HOWEVER, HE WILL LEAVE THE NAIL IN AND MONITO

  Patient problems: Arthralgia; Neck Pain

  MAUDE report 14350876 ↗